A large number of active pharmaceutical ingredients may be administered by the use of a chewing gum. An example of this is known from e.g. WO 02/102357 disclosing a coated nicotine-containing chewing gum.
The use of chewing gum to administrate nicotine has been known for several years, in which the nicotine may be mixed with the gum base and/or added as part of the coating.
The addition of nicotine as part of the coating often favors a fast release of the nicotine; however with too fast release, substantial amounts of the nicotine may be lost because it reaches the stomach and is digested without providing the desired relief from cravings. Hereby it may happen that only a minor part of the fast released nicotine is being absorbed by the mucous membrane, where it becomes effective.
The mixing of nicotine with the gum base may be an alternative. Nicotine release from the gum base may be comparatively slow and the nicotine release may be adjusted to cover a prolonged period of time. However the release of nicotine from the gum base may in this case end up being too slow whereby a significant amount of the nicotine is trapped in the gum base and not released to relief nicotine cravings.
A challenge related to the use of active pharmaceutical ingredients in chewing gum is that the active pharmaceutical ingredients should be administered as effectively as possible to the user. In the case of nicotine as the active pharmaceutical ingredient this includes both the amount of nicotine absorbed through the mucous membrane and the amount of nicotine in the chewing gum actually released and utilized to relief the cravings of the user, thereby providing an effective alternative to the smoking of a cigarette.
It is an object of the present invention to provide an improved and effective administration of active pharmaceutical ingredients such as nicotine to users of medicated chewing gum.